Clearance Summary
ISE CALIBRATORS FOR CORNING 600 SERIES ANALYZERS received FDA 510(k) clearance under submission number K930796, sponsored by Alko Diagnostic Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1994-01-13.
- Submission: K930796
- Applicant / Sponsor: Alko Diagnostic Corp.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.4830
- Decision date: 1994-01-13
Classification & Regulation
This clearance is catalogued under FDA product code JZX and 21 CFR 866.4830, within the Immunology review panel as a Class I device.